Bothell-Based Natural Remedy Company Receives Investigational New Drug Number from FDA.

BOTHELL, Wash. -- JBNI currently conducting human trial for asthma therapy; in negotiations with leading pharmaceutical companies to sell product

JBNI, Inc., a pioneer in researching, developing, and distributing safe and effective natural remedies, has received an Investigational New Drug (IND) number from the FDA for the clinical testing of a product for the treatment of asthma.

The Phase 3 clinical trial, a double-blind placebo-controlled crossover study of 60 patients at three sites, is currently underway in conjunction with the University of New England College of Osteopathic Medicine. Results are expected in 90 to 120 days, after which JBNI will begin the New Drug Application (NDA) process.

While the trial continues, JBNI is in discussions with leading pharmaceutical companies and investment bankers to purchase the product and take it through the approval process.

One of the nation's most common and costly diseases according to the U.S. CDC, asthma has a substantial impact on health, quality of life and the economy.

With 18 million people in the U.S. living with asthma, according to the U.S. National Heart, Lung and Blood Institute, annual medical and indirect expenses in the U.S. because of asthma is estimated at $16.1 billion.

The American Lung Association reports that asthma results in:

--Approximately 5,000 deaths per year

--Two million emergency room visits

--Nearly 500,000 hospitalizations

--14 million missed school days

--14.5 million missed work days

The U.S. retail market for asthma was estimated at $ 4.7 billion in 2001.

"The results from the preliminary trials justify moving this agent through to the next stage of clinical testing," said E. J. Lovett III, Ph.D., principal of Lovett Collins Associates, LLC, which is managing the trial for the university. "Our investigators are eager to test its effects in asthma."

The FDA's role in the development of a new drug begins when the drug's sponsor has documented pharmacological activity, has conducted safety and toxicity research and wants to test its diagnostic therapeutic potential in humans. In order to transport or distribute the substance across state lines for further testing, an IND must be obtained from the FDA, demonstrating its safety, purity, manufacturing processes and facilities and documenting the substance will not expose trial subjects to an unreasonable risk when used in early-stage clinical trials.

JBNI currently produces and markets more than 20 specialized products for conditions including pain and inflammation, menopause, depression and migraines. All the company's products have undergone a rigorous testing and evaluation process.

About JBNI

Founded in 1993, Bothell, Wash.-based JBNI researches, develops and distributes unique and highly effective natural remedies based on sound scientific principles and cutting edge technology. For more information, medical professionals should call 425-408-9091.

-- Please note that these statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.